A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

lixisenatide once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Starting dose will be 10µg, then increased to the 20µg maintenance dose after 2 weeks

Drug: lixisenatide (AVE0010)

Pharmaceutical form:solution for injection (disposable self injector)

Route of administration: subcutaneous injection

Active Comparator: insulin glulisine once a day

Insulin glulisine once a day (injected before breakfast or dinner) on top of insulin glargine with or without metformin. Treatment will be initiated and then individually titrated

Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and ≥20 U/day for at least 2 months prior to visit 1.

Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (≥1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

At screening: age < legal age of majority

At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP-4 inhibitor and/or a glinide.

Women of childbearing potential with no effective contraceptive method, pregnancy or lactation

Type 1 diabetes mellitus

Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.

Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.

Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.

At screening, Body Mass Index (BMI) ≤20 or >40 kg/m².

Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.

Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.

Exclusion Criteria for randomization at the end of the screening period before randomization:

HbA1c <7.0% or >9.0%.

7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).

Amylase and/or lipase > 3 times ULN.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01768559